Orthotic device for preventing and/or correcting deformational posterior plagiocephaly

ABSTRACT

The present invention is a simple, adaptable orthotic device that can correct and/or prevent deformational posterior plagiocephaly, especially if used before the infant is 4 months of age. The manufactured article provides an anatomically correcting, adjustable, concave-shaped resting surface for an infant&#39;s head in a manner that effectively eliminates uneven pressure on the infant&#39;s occiput. The orthotic device has a modular design which permits easy adjustments of the devices&#39; head cavity to accommodate differences in individual infant head size and shape, thereby providing the infant&#39;s head with a custom fit. Also, as the infant continues to grow in size, the adjustable head cavity and torso recess features of the orthotic device allow the contoured spatial volume and dimensions of the molded supporting surfaces to expand as the infant&#39;s calvaria grow; and thereby facilitate a progressive, normalization and rounding of the infant&#39;s occiput.

PRIORITY CLAIM

This application is a Continuation application of a U.S. applicationSer. No. 11/859,887 filed on Sep. 24, 2007, now issued U.S. Pat. No.7,810,501, which is a co-pending International application No.PCT/US2006/010397, filed Mar. 22, 2006, which designated the U.S., andwhich claims the benefit under 35 U.S.C.§119(e) of U.S. ProvisionalApplication No. 60/664,491, filed Mar. 23, 2005.

FIELD OF THE INVENTION

The present invention is concerning generally with manufactured articlesuseful as a prophylactic against and treatment for pediatric developmentdisorders; and is particularly directed to orthotic devices forpreventing or correcting deformational posterior plagiocephaly.

BACKGROUND OF THE INVENTION

The Medical Need

The “Back to Sleep” campaign has been a great success, reducing thenumber of infant deaths from Sudden Infant Death syndrome (“SIDS) by 25%since its inception in 1992. By one estimate, the risk of death due toSIDS is two times greater while sleeping in a prone position than whenthe child lies in a supine position. Perhaps then, it not surprisingthat for infants sleeping in a prone position the death rate declinedfrom 70% in 1992 to 24% in 1996 [National Center for Health Statistics,Center for disease Control and Prevention].

Along with positional advice, the American Academy also recommendsavoiding soft and gas trapping surfaces in cribs and eliminating “tummytime” while the infant is awake. Under certain circumstances (such asgastroesophageal reflux, upper respiratory tract obstructions orinfectious diseases, etc), a pediatrician may weigh the risks andrecommend a prone position. However, one side effect of the “Back toSleep” campaign has been the marked rise of plagiocephaly, anddeformational posterior plagiocephaly in particular [Pollack et al.,“Diagnosis and Management of Posterior Plagiocephaly”, Pediatrics, Vol.99, No. 2, February 1997].

The Problem of Plagiocephaly:

Plagiocephaly typically progresses most in infants ranging between birthand 3-4 months of age. Deformational posterior plagiocephaly is alocalized flattening of the cranium, usually near the occiput. Thispathological condition is illustrated by FIGS. 1A and 1B respectively.

As seen therein, FIG. 1A provides an overhead view of an infant withdeformational plagiocephaly; and FIG. 1B schematically illustrates thepositional deformation of the soft infant cranium causing unilateralflattening in the parieto-occipital region, anterior advancement of theipsilateral ear, and associated anterior displacement of the ipsilateralforehead.

Deformational posterior plagiocephaly occurs most often in infants offour months age or younger because (i) the skulls of young infants arestill easily deformed; (ii) the posterior calvaria are rapidly expandingagainst a flat surface; and (iii) such infants are neuromuscularlyimmature and lack the coordination to shift their head position. If leftuncorrected, the pressure forces will likely remain continuously applieduntil the infant reaches 6-8 months of age, whereupon the existingdeformation will likely become permanent.

Infants with torticollis (wry neck) are particularly at risk forposterior plagiocephaly since their condition will make them favorturning their head one way. By definition, torticollis is a congenitalor acquired condition of limited neck motion in which the child willhold the head to one side with the chin pointing to the opposite side;and is the result of the shortening of the sternocleidomastoid (neck)muscle. Thus, as a consequence of the positioning of the headcontinually in one side position, the infant suffers from the flatteningof that side of his head. This asymmetrical plagiocephaly isparticularly disfiguring in appearance.

It as been recognized that the vast majority of infants with occipitalflattening do not have Craniosynostosis—a premature obliteration of thesutures which results in skull deformity and potential restricted growthof the brain. Also, Lamboid Synostosis, which can mimic deformationalposterior plagiocephaly, is remarkably rare, occurring only in anestimated 20 per million live births. Thus, occipital flattening isabout 5000-8000 times more likely to occur from a deformation processthan from a sutural fusion.

Incidence of Posterior Plagiocephaly:

The incidence rate of posterior plagiocephaly in some infant populationscan be as high as 48%. By contrast, the incidence rate ofcraniosynostosis is only about 1 in 3,000 infants [Bruneteau, R J. & J.B. Mulliken, “Frontal Plagiocephaly: Synostotic, Compensational, OrDeformational”, Plastic and Reconstructive Surgery 89(1):21-31 (January1992)].

Actual incidence rates vary by patient population and age; and will beinfluenced by cultural habits for positioning resting newborns. Also, aswith all diseases, the severity of the posterior plagiocephaly comes indegrees. Nevertheless, any kind of plagiocephaly is very unnerving forparents to live with.

Research at Children's Hospital and Harvard Medical School in 2002 byDr. Peitsch and others indicated that 13% of all single-birth newbornsand 56% of all twins had localized cranial flattening, a possibleprecursor to posterior plagiocephaly [Peitsch et al., “Incidence ofCranial Asymmetry in Healthy Newborns”, Pediatrics 110(6):e72 (December2002)]. A further 10% of all infants suffer from congenital torticollis,which will exacerbate a tendency towards posterior plagiocephaly.

Furthermore, about 25,000 infants are referred to us specialists everyyear for treatment from plagiocephaly. With 4.6 million live births inthe U.S. annually, there are likely to be at least 600,000 infants borneach year in need of corrective treatment for plagiocephaly; andprophylactic measures to prevent or avoid deformational posteriorplagiocephaly would benefit all newborns.

Conventionally Known and Used Therapeutic Techniques:

As conventional corrective measures, the overwhelming majority ofinfants with occipital flattening have been treated to date usingtherapies that redistribute the weight-bearing load on the posteriorcalvaria. The therapies typically include several different categoriesor techniques. These include the following general categories:

(A) Simple positioning and re-positioning therapy which encouragesparents to shift the infant's sleep position periodically through thesleep periods;

(B) The use of wedge or doughnut shaped support pillows that redirectthe pressure of the head in its resting position to the side of thehead;

(C) The use of tiltable mattresses or beds that relieve the pressure onthe occipital prominence of the head and distribute the pressure over awider surface area; and

(D) The use of orthoplastic helmets or headbands that apply differentialpressure to the head of an infant.

Because plagiocephaly typically progresses most in infants ranging inage from birth to about 4 months, many physicians recommend infantrepositioning and observation, presumably because there is hope ofspontaneous correction; and because the infant may be viewed as beingtoo underdeveloped for helmet therapy.

Also, anxious parents often purchase off-the-shelf orthotics and wedgesin an attempt to prevent further deformation of their baby's head andface. However, most parents report poor results using these modalities;and eventually seek further medical consultation with a specialist. Intrue fact, there is no clinical data available to date whichsubstantiates the alleged corrective benefits of any commercially soldorthotic, other than the molding helmet.

In addition, while the molding helmet is effective to treat moderate orsevere cases of deformational plagiocephaly, such helmets are far toocostly and cumbersome for use in minor cases, or as a prophylaxis inhigh-risk patients (i.e., early plagiocephaly, severe torticollis,premature infants, etc.). Additionally, insurance companies are lessinclined to cover the cost of the molding helmet since, in theiropinion, such calvarial flattening is considered to be merely“cosmetic”.

Relevant Publications

The published literature provides many descriptive instances for thesevarious approaches. Merely as an aid, a summary of some relevant legalpublications includes the following:

Illustrating the use of shaped support pillows for Category B above are:U.S. Pat. Nos. 6,052,849; 6,473,923; 6,564,408; 6,006,381; 6,226,817;6,460,207; and Published U.S. Patent Applications Nos. 2002/0042954 A1,and 2004/0172762 A1.

Representing the use of tiltable mattresses or beds for Category C aboveare: U.S. Pat. Nos. 6,421,855; 6,260,553; D448,227; 5,581,832; andPublished U.S. Patent Applications Nos. 2003/0033674 A1, 2001/0042269A1, 2002/0174488 A1, and 2003/0145384 A1.

Exemplifying the use of orthoplastic helmets and headbands for CategoryD above are: U.S. Pat. Nos. 4,776,324; 6,592,536; 6,266,832; 5,094,229;5,038,312; 5,915,503; 6,346,353; and Published U.S. Patent ApplicationsNos. 2003/0195450 A1, and 2004/0015118 A1.

Nevertheless, despite all these developments to date, there remains arecognized and continuing need for further improvements in devices andprocedures which can correct and/or prevent deformational posteriorplagiocephaly. All such improvements in such singular medical devicesand effective treatment techniques would be readily seen as a majorcontribution and outstanding benefit in this medical field.

SUMMARY OF THE INVENTION

The present invention has multiple aspects.

A first aspect of the present invention provides an orthotic device fortreating posterior plagiocephaly in an infant, said orthotic devicecomprising:

a base substrate having fixed dimensions and configuration, andcomprising at least one thermoformable material having a densitysufficient to maintain its material integrity under load;

an anatomically correcting head cavity molded into said base substrateale to receive and support the occiput of an infant's head, saidanatomically correcting head cavity presenting a molded maximalcontoured outline and spatial volume for normalizing and rounding theocciput of an infant's head;

a plurality of discrete layers of material serving as a series ofprepared individual liners which can be positioned in overlay serieson-demand within the molded spatial volume of said head cavity, can beindividually removed at will from the positioned overlay series lyingwithin the spatial volume of said head cavity, and, via their presencewithin said head is cavity, can alter the available contoured outlineand spatial volume presented by said head cavity for normalizing androunding the occiput of an infant's head; and

a bridge section of constant dimensions and configuration which isdisposed on said base substrate adjacent to said head cavity and servesto support the neck of a infant during the normalizing and rounding ofthe occiput in an infant's head.

A second aspect of the present invention provides an orthotic device fortreating posterior plagiocephaly in an infant, said orthotic devicecomprising:

a base substrate having fixed dimensions and configuration, andcomprising at least one thermoformable material having a densitysufficient to maintain its material integrity under load;

an anatomically correcting head cavity molded into said base substrateale to receive and support the occiput of an infant's head, saidanatomically correcting head cavity presenting a contoured outline andspatial volume of molded maximal dimensions for normalizing and roundingthe occiput of an infant's head;

a plurality of discrete layers of material serving as a series ofprepared individual liners which can be positioned in overlay serieson-demand within the molded spatial volume of said head cavity, can beindividually removed at will from the positioned overlay series lyingwithin the spatial volume of said head cavity, and, via their presencewithin said head cavity, can alter the available contoured outline andspatial volume presented by said head cavity for normalizing androunding the occiput of an infant's head;

an anatomically correcting torso recess molded into said base substrateale to receive and support the torso of an infant's body, saidanatomically correcting torso recess presenting a spatial volume havingfixed width and length dimensions and a molded maximal depth dimensionfor supporting the infant's torso;

a plurality of discrete layers of material serving as a series ofprepared individual liners which can be positioned in overlay serieson-demand within the molded depth dimension of said torso recess, can beindividually removed at will from the positioned overlay series lyingwithin the molded depth dimension of said torso recess, and, via theirpresence within said torso recess, can alter the available dimensionaldepth presented by said torso recess for supporting an infant's torso;and

a bridge section of constant dimensions and configuration which isdisposed on said base substrate adjacent to said head cavity and saidtorso recess which serves to support the neck of a infant during thenormalizing and rounding of the occiput in an infant's head.

BRIEF DESCRIPTION OF THE FIGURES

The present invention can be more easily understood and betterappreciated when taken in conjunction with the accompanying Drawing, inwhich:

FIG. 1A is an overhead view of an infant with deformationalplagiocephaly;

FIG. 1B is a schematic illustration demonstrating positional deformationof the soft infant cranium causing unilateral flattening in theparieto-occipital region, anterior advancement of the ipsilateral ear,and associated anterior displacement of the ipsilateral forehead;

FIG. 2 is an overhead view of a first preferred embodiment of theorthotic device comprising the present invention;

FIG. 3 is a view of the head cavity in the first embodiment of FIG. 2;

FIG. 4 is a view of the discrete layers of solid material lying withinthe head cavity and torso recess of the first embodiment of FIG. 2;

FIG. 5 is a detailed view of the discrete layers of solid material inthe first embodiment of FIG. 2;

FIG. 6 is an overhead view of a second preferred embodiment of theorthotic device comprising the present invention;

FIG. 7 is a view of the anatomically correct shape of the head cavity inthe second embodiment of FIG. 6;

FIG. 8 is a view of the anatomically correct shape of the torso recessin the second embodiment of FIG. 6;

FIG. 9 is an overhead view of an alternative embodiment of the presentinvention wherein only a head cavity exists, without any torso recessbeing present; and

FIG. 10 is a frontal view of the alternative embodiment in FIG. 9.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is a simple, adaptable orthotic device that cancorrect and/or prevent deformational posterior plagiocephaly, especiallyif used before the infant is 4 months of age. The manufactured articleis an anatomically correcting, repeatedly adjustable, concave-shapedresting surface for an infant's head in a manner that effectivelyeliminates uneven pressure on the infant's occiput.

Equally important, the orthotic device has a modular design whichpermits easy initial adjustment(s) of the head cavity to accommodatedifferences in individual head size and head shape, thereby providingthe infant with a personalized custom fit. Thus, as the infant grows anddevelops over time, the adjustable head cavity feature of the orthoticdevice allow the contoured spatial volume and dimensions of the moldedsupporting surfaces in the orthotic device to expand and enlarge as theinfant's calvaria grow; and thereby facilitate a progressive,normalization and rounding of the infant's occiput. In addition, theposterior neck area of the infant is supported by a fixed bridgesection, which also serves to off-load or reduce contact pressurebetween the rest surface and the occiput, especially as the cavity ofthe device deepens.

The present invention thus provides a number of different majoradvantages and unusual benefits for the user. These include:

1. None of the conventionally available plagiocephaly correctivesupports allow for a size-adjustable molded support which can be changedover time. One size cannot provide an appropriate molding surface forall infants of any age; and therefore, one size fits none. In contrastto other devices, such a size-adjustable feature and capability isprovided by the present orthotic device, and an adjustable surface canbe fashioned via the use of removable individual layers of material.

2. The conventionally available plagiocephaly corrective supports aretypically manufactured using extremely soft substances, such as softfoam or fiber-filled pillow material. Although the soft and comfortablefeel of these materials is reassuring to the parents of the infant,these types of substances do not provide sufficient firmness to maintainthe corrective cavity form needed to mold the infant's skull.

In comparison, the present orthotic device is firm, durable andbiocompatible; and provides a pressure-resistant, molded head cavitywhich is an anatomically correcting template for the proper reshaping ofthe infant's head. This is a unique feature and function of the orthoticdevice.

3. It is recognized and accepted that the conventionally known wedgeshaped pillows can enforce side-to-side sleep position, but cannot serveas a mold for the correct had shape. Similarly, the dough-nut shapedpillows can prevent infant head turning, but do not correctly normalizeand round the head shape of the infant; instead, they merely create“dough-hole” protuberances onto the back of the infant's skull.

4. The expandable shape of the present invention allows for the use ofone bed, pad, or mattress over many weeks or months time. This costsaving can be considerable.

5. The present invention is neither cumbersome nor difficult to use; andwill provide an improved compliance by the parents of the infant and agrater probability for a successful treatment and correction ofdeformational posterior plagiocephaly.

I. The Structural Features of the Orthotic Device

The orthotic device comprising the present invention is a firm, moldedsupport article having at least one, and preferably two, specificallyconfigured concave hollows or molded depressions into which the infant'shead—and preferably the infant's torso as well—will fit snugly, whilethe infant lies in a supine position (i.e., lying prone or faceupwards).

A First Embodiment of the Orthotic Device

A first illustrative example of the orthotic device is shown by FIGS.2-5 respectively. As seen therein, the orthotic device appears asprepared bed, pad, or mattress 2 comprising an underlying base substrate10; an anatomically-correcting concave head cavity 12 which is shapedand sized to receive and support at least the parieto-occipital regionof the infant's head; an anatomically-correcting concave torso recess 14which is configured and dimensioned to receive and support the infant'sneck and shoulders; and a neck bridge section 16 lying between andadjacent to each respective concave spatial depression 12, 14.

The Base Substrate

In preferred embodiments of the prepared bed, pad, or mattress, theoverall base substrate 10 is a planar tier (or alternatively a stage orsheet) of fixed dimensions. This planar tier is desirably about 75 mm inthickness because the overall fixed dimensions of the base substrate 10must provide two different capabilities: the base substrate must besufficient in thickness (as well as having sufficient length and width)to hold and contain the largest spatial volume and deepestperimeter/contour outline which is anatomically corrective for both thehead cavity 12 and the torso recess 14 respectively; and the basesubstrate also must be adequate in material substance to support theinfant's head and torso when these body parts are placed into theanatomically-corrective molded spaces intended to receive them.

Accordingly, to achieve this purpose, it is intended and expected thatthe planar tier comprising the base substrate 10 will be constructed ofa firm biocompatible and durable composition (or an admixture ofdifferent chemical compositions) that does not permit substantialpressure distortion; is able to function as an underlying supportivestage or sheet of material; and will typically vary in overall thicknessfrom about 50-100 mm.

The Molded Maximal Spatial Volumes for Receiving the Head and Torso

The molded head cavity 12 and the molded torso recess 14 respectivelydefine two different, specially configured, maximal spatial volumeswhose individual dimensions, depth, contours, and perimeter size areencompassed and controlled by at least one surrounding, molded solidwall. This molded, maximum-volume, solid material wall, (or, in thealternative, walls) is composed of a firm biocompatible and durablematerial that does not allow for meaningful pressure distortion of theshaped contours and perimeters defining these anatomically-correctconcavities.

In this manner, by maintaining the purposeful concave shape and maximalvolume of the head cavity 12 and of the torso recess 14, the orthoticdevice serves as an anatomically-correcting medical article; andprovides a prepared therapeutic/prophylactic template against which theoccipital bones in the infant's head can normalize and become roundedover time.

In effect, the concave spatial depressions of the orthotic device act toalter the shape of the infant's growing calvaria. The dimensions andconfiguration of the molded spatial depression constituting the headcavity 12 will off-load pressure from the flattened area then existing(or threatening to become present) in the infant's skull; and the shapeof the infant's head will grow more symmetric and rounded over time,until the infant's head shape ultimately conforms to theanatomically-correct configuration of the concave head cavity (which isperfectly concave and formed to a cephalic index, or width/length ratio,of 0.75).

Accordingly, as the flattening of the skull corrects over time, theinfant's occiput will experience even pressure from all sides of theconcave cavity. Hence, by employing the same deformation mechanism thatcaused the initial flattening of the infant's head (calvarial growthagainst a flat surface), the concave cavity 12 serves as a head supportand produces occipital rounding (calvarial growth against a concavesurface).

Multiple Layers of Solid Material

The concave head cavity 12 and the torso recess 14—the molded maximalspatial volumes intended to receive the head and torso of the infantrespectively—are modified, controlled, and formed using multiple layers20 of individual material inserts which are arranged and aligned inoverlay series. In each of these concavities, the individual materiallayers 20 will be positioned one over the other as multiple strata inoverlay array series, and typically will appear as an arranged stack oflayers 22.

Thus, it is expected that when constructing the exemplary embodimentshown by FIGS. 2-5 respectively, one or more successive layers (of solidmaterial) are initially present and collectively will form part of thesolid material wall which then encompasses, dimensions, andquantitatively defines the spatial volume then existing within eachmolded depression. Via this arrangement, each discrete layer 20 (ofsolid material) can be retained if so desired; or alternatively, eachdiscrete layer can be individually removed on-demand to enlarge thepresently existing total spatial volume and concomitantly increase thedepth of either (or both) the head cavity 12 and the torso recess 14 toaccommodate the head and body changes which invariably occur as theinfant grows in age and size. Furthermore, any previously removed layer20 also can be optionally re-inserted into the stacked array at will todecrease an earlier-made modification of spatial volume.

This capability either to retain if desired, or to remove at will, andoptionally to re-insert if needed, one or more individual layers ofmaterial repeatedly on-demand for either or both molded spatialdepressions is an unique capability and structural feature. Thiscapability allows the parent or child caretaker to modify each spatialvolume separately, such that the head cavity and the torso recessbecomes individually fitted and custom sized multiple times over time tomeet the ever changing size requirements of the infant's growing headand torso.

It will be appreciated therefore that, in preferred constructions of thehead cavity 12 and of the torso recess 14, eight individual layers 20 ofmaterial have been placed into an array 22 and used to advantage withineach molded concavity; and this array 22 of eight layers generates analterable on-demand solid material wall which, on each occasion ofalteration, differently encompasses and defines the volume and depthdimension then present for each of the molded spatial depressions.

In these preferred examples, each discrete layer of material istypically about 3-4 mm thick. However, it is expected and intended thateach individual material layer in employed in series may range from 2-6mm in thickness; that the number of individual material layers arrangedin such overlay series (i.e., as a stack) may routinely vary from 3-12discrete layers.

The Neck Bridge Section

In this embodiment, the molded spatial depressions 12, 14 intended toreceive and support the head and torso of the infant are optionally, butpreferably separated by a discrete bridge section 16, which is comprisedof firm support material and upon which the back of the infant's neck isintended to rest. When present, this neck bridge section 16 is notadjustable in thickness (girth) or height; and will not affected if andwhen one or more successive layers of material originally present aspart of the head cavity 12 and the torso recess 14 are removed.Accordingly, the neck bridge 16 spanning the distance between the twospatial volume depressions 12, 14 should always remain at one fixedheight.

By this structural relationship, the depth of the head cavity 12 and thetorso recess 14 relative to the bridge section 16 becomes increased aseach individual layer of material is successively removed from the twospatial depressions; but the height of the bridge section itself remainsconstant and uniform. This constancy of neck bridge height andsupport—despite the ever increasing deepening of the head cavity 12 andthe torso recess 14—is a singular feature which allows the infant's headand body to remain level; and also prevents the infant's head from beingpushed towards its chest as the infant's head grows in size over time.

A Second Embodiment of the Orthotic Device

A second example of the present invention is shown by FIGS. 6-8respectively; and is a construction which is a complete rendering andrecapitulation of the first embodiment described above, but is anarticle which has one additional structural feature. In this secondformat, the overall substance and appearance of the base substrate maybe tapered or sloped over its length, width, and thickness dimensions;and this tapering effect results in a mattress pad which is slanted orinclined at a determinable angle from top surface to bottom surface andfrom front end to back end.

The inclined base substrate, as shown in the exemplary model of FIG. 6,is intended and expected to be a marked improvement over non-inclinedversions; and will protect the supine positioned infant better againstattacks of gastric reflux.

II. Configurational Details of the Molded Spatial Concanvities The HeadCavity

The contours, volume and dimensions of the head cavity provide a moldedand anatomically correct shape for receiving an infant's head. Thisaspect and detail of the invention is shown in detail by FIGS. 3 and 7respectively.

As seen therein, the spatial outline of the head cavity shows its moldedshape to be anatomically correct; and the separate discrete layers ofmaterial lining the interior of the spatial depression and forming thebuilt-up outline for receiving the infant's head appear partiallyseparated at the front of the cavity. Note that the neck bridge section(seen as a line of darker colored matter in FIG. 2) remains constant inheight and physically separates the head cavity and torso recessportions of the orthotic device.

In this example, the width dimension of the base substrate is about 40cm, and the length dimension is about 70 cm; and while the maximumthickness of the base substrate is about 75 cm, the thickness dimensionat the deepest part of the head cavity {i.e. with all the individuallayers of material removed from the cavity space) is about 10 cm.

The Anatomically Correct Shape of the Head Cavity

The anatomically correct head shape can be defined by mathematicalderivation using standard head circumference charts [see for example,http://www.cdc.gov/growchai-ts]; and by assuming a normal cephalic indexof 0.75.

Empirical measurements showed that a neck support of about 1.0 cm (asmeasured from upper back to midcervical spine) provided a comfortableposition of neck extension to a newborn infant without causing excessivecervical lordosis {i.e., a curvature of the spine that is concave towardthe rear). Also, to maintain the neutral neck lordosis, thisrelationship is increased to 2.0 cm by infant age 5 months. Thesemeasurements are derived from mean values, and will vary based uponindividual head circumference. However, the ability to remove one ormore discrete layers of material allows a parent or care-giver to adjustthe overall spatial dimensions and volume of the cavity to accommodateand custom fit any infant's head.

An Exemplary Model

To illustrate this technical point even further, some examples of thealtered and changed spatial volume and dimensional outlines for the headcavity, that are obtainable at will and can be created upon removal ofone or more successive layers of material, are as follows:

-   -   The head cavity measures 8.8 cm wide, 9.0 cm tall, and 0.6 cm        deep (from upper cervical spine to occipital prominence). These        dimensions represent the anatomically correct size for a        premature or small-for-age infant. All the removable at will        layers of material are positioned in overlay series and are in        proper place within the head cavity.    -   The head cavity measures 9.4 cm wide, 9.3 cm tall, and 0.9 cm        deep (from upper cervical spine to occipital prominence). These        dimensions represent the correct size for an average term        infant. Layer 1 (the uppermost layer) has now been removed from        the overlay series.    -   The head cavity measures 10.0 cm wide, 9.6 cm tall, and 1.2 cm        deep (from upper cervical spine to occipital prominence). These        dimensions represent the correct size for an average term infant        of approximately 4 weeks of age. Layer 2 has also now been        removed from the overlay series.    -   The head cavity measures 10.6 cm wide, 9.9 cm tall, and 1.5 cm.        deep (from upper cervical spine to occipital prominence). These        dimensions represent the correct size for an average term infant        of approximately 8 weeks of age. Layer 3 has also now been        removed from the overlay series.    -   The head cavity measures 11.2 cm wide, 10.2 cm tall, and 1.8 cm        deep (from upper cervical spine to occipital prominence). These        dimensions represent the correct size for an average term infant        of approximately 12 weeks of age. Layer 4 has also now been        removed from the overlay series.    -   The head cavity measure 11.8 cm wide, 10.5 cm tall, and 2.1 cm        deep (from upper cervical spine to occipital prominence). These        dimensions represent the correct size for an average term infant        of approximately 4.5 months of age. Layer 5 has also now been        removed from the overlay series.

Spaces or cut-outs intended for the ears of the infant are also linedwith removable layers of material (confluent with the series of linersfor the head) and are adjusted (widened in the cephlad/caudad dimensionand deepened) as the occipital cavity deepens.

The Torso Recess

The overall shape and volume of the torso recess is sized to provideadequate width and length dimensions to receive and accommodate theinfant's body. This is illustrated by FIGS. 2, 6, and 8 respectively.

The width and length dimensions of the preferred torso recess preferablywill not and do not change as the depth dimension is adjusted andaltered via the successive removal of individual layers of material.Thus, it is most desirable that the layers of material lining thespatial volume of the torso recess be arrayed in overlay series suchthat only the depth dimension of the concavity is affected when one ormore individual layers of matter are removed.

An Exemplary Model

To illustrate this technical point even further, some examples of thealtered and changed spatial volume and depth dimensions for the torsorecess, that are obtainable at will and can be created upon removal ofone or more successive layers of material, are as follows:

-   -   The torso recess measures 0.6 cm deep (from upper cervical spine        to occipital prominence). These dimensions represent the        anatomically correct size for a premature or small-for-age        infant. All the removable at will layers of material are        positioned in overlay series and are in proper place within the        torso recess.    -   The torso recess measures 0.9 cm deep (from upper cervical spine        to occipital prominence). These dimensions represent the correct        size for an average term infant. Layer A (the uppermost layer)        has now been removed from the overlay series.    -   The torso recess measures 1.2 cm deep (from upper cervical spine        to occipital prominence). These dimensions represent the correct        size for an average term infant of approximately 4 weeks of age.        Layer C has also now been removed from the overlay series.    -   The torso recess measures 1.5 cm deep (from upper cervical spine        to occipital prominence). These dimensions represent the correct        size for an average term infant of approximately 8 weeks of age.        Layer D has also now been removed from the overlay series.    -   The torso recess measures 1.8 cm deep (from upper cervical spine        to occipital prominence). These dimensions represent the correct        size for an average term infant of approximately 12 weeks of        age. Layer E has also now been removed from the overlay series.    -   The torso recess measures 2.1 cm deep (from upper cervical spine        to occipital prominence). These dimensions represent the correct        size for an average term infant of approximately 4.5 months of        age. Layer F has also now been removed from the overlay series.

Identification Aids for the Individual Layers of Material

It will be noted and appreciated also that, in order to facilitate theproper and correct usage of the orthotic device, the different andsuccessive layers of material can be labeled, or colored, or otherwiseidentified as to their proper placement, alignment, orientation withinthe arranged overlay series of discrete layers. Such labeling andidentifications means may include:

-   -   The age in weeks of an infant for which the individual layer is        appropriate.    -   The head circumference of an infant for which that layer is        appropriate.    -   Successive numbers (Arabic or Roman) or alphabet letters        (English, Greek, or any other language) that correspond to        instructions provided separately in written, audio, or video        format.    -   Differentiating colors that correspond to instructions provided        separately in written, audio, or video format.

III. Alternative Embodiments of the Orthotic Device

A number of different designs and singular organizational formats can beemployed as alternative embodiments of the orthotic device. All of theseare deemed to be within the purview and scope of the subject matter as awhole which is the present invention.

A Head Rest Format

In this 1^(st) alternative format, the design of the head cavity andbridge section (supporting the neck) may be manufactured singly withoutany torso recess for use as a discrete head rest. An illustration ofthis alternative format and construction is shown by FIGS. 9 and 10respectively.

As seen therein, this head rest format of the invention provides a headcavity only, with no torso recess as such. As shown by FIGS. 9 and 10,the multiple layers of material lining the spatial volume of the headcavity have been intentionally removed in order to visualize better thecomplete absence of any molded depression for the torso of the infant.

In this alternative structural construct, the head rest format is thedesired article. The head rest of FIGS. 9 and 10 may be placed on top ofa mattress pad, a car seat, or any other resting surface. The infant'shead is to be placed in the head cavity of the orthotic device, but theinfant's torso and body must lie on the resting surface existing in-situat that particular location. The infant's shoulders are supported by asmall wedge that is tapered caudally. The distance between the neckbridge support and the infant's back does not change and cannot beadjusted. The bridge support for the neck protrudes about 10-1.5 cm fromthe upper back to off-load pressure between the infant's occiput and theresting surface in-situ.

Materials for the construction of this 1^(st) alternative embodiment,the head rest format, are as described generally below for preferredembodiments of the invention. Particular design specifications for thehead cavity and the bridge support are as described earlier herein forthe full mattress design.

A Re-Sculpted Spatial Depression Format

As a second alternative embodiment, an orthotic device comprising a basesubstrate having a head cavity and neck bridge support (with or withoutan accompanying torso recess) is custom made for the individual infantby a licensed orthotist. Because of the very precise adjustmentspermitted, this format of the orthotic device can be used to affectspecific and individualized correction of occipital flattening. Theconstruction is custom made and personally fitted to meet the infant'spersonal size specifications using the materials described hereinafter.Then, as the infant grows, the spatial volume, contours, and dimensionsof the head cavity (and optionally the torso recess) is modified andenlarged repeatedly on multiple occasions, by the licensed orthotist toallow for calvarial expansion and infant growth over time.

Incorporation of the Invention into Infant Rest and Carriage Products

It is expected and intended that any or all of the different embodimentsand formats of the present invention can be incorporated and be mergedwith a diverse range of other infant items; and that such collectionscan be prepared as an unified design and be produced as a singlemanufactured unit.

The typical variety of these other infant items is conventionally knownand is commonly available from many commercial sources. These otherinfant items include: a bassinet; crib; bed; carriage; pram; stroller;carrier; car seat; chair; high chair; swing; rocker; mattress; mattresspad; diaper-changing pad; or any other infant seating, resting, orcarrying article.

IV. Suitable Materials for Constructing Any Format of the OrthoticDevice

In preferred and alternative embodiments of the orthotic device, theentire manufactured mattress—including the base substrate, head cavity,torso recess, and neck bridge section—have been constructed and formedusing individual, pre-sized layers of VOLARA® foam (a smooth surfaced,fine closed-cell structure, polyethylene foam). Specifically, the typeof VOLARA® foam preferably used for manufacturing purposes is Grade EOclosed-cell polyethylene foam having a density of 4 lbs. per cubic foot.

A number of other conventionally known and commercially available foamsexist that are suitable for making the present invention. Thesealternatives include: Pelite; Plastizote; T-foam; or other formulatedfoams having physical and chemical properties similar to these.

As an additional guide, the essential properties that at least one foammaterial (of any known chemical composition or formulation) be employed,and that this foam should demonstrably provide and include, but are notbe limited to, the following properties: (i) being a thermoformablematerial; and (ii) having a density substantial enough to maintain itsintegrity as a foam during physical load, but also being soft enough toallow long periods of use without causing adverse skin reactions.

In constructed prototypes of the molded head cavity and the torso recessin the mattress, 8 individual layers of foam have been used toadvantage. In these instances, each individual foam layer is about 3-4mm thick. However, it is expected and intended that each discrete foamlayer may range from 2-6 mm in thickness; and that the total number ofindividual foam layers—arranged in overlay series to generate theconfigured head cavity and torso recess of the mattress—can vary from3-12 discrete and separate foam layers.

VOLARA Foams

VOLARA is a federally registered trademark originally held by Voltek LLC(Lawrence, Mass.). However, Voltek LLC has been acquired by SekisuiAmerica Corp.; and they now hold the trademark rights and commerciallymanufacture foam products at the same geographic location. Informationconcerning the grades and mechanical properties of the various VOLARA®foams that are commercially sold can be viewed athttp://www.voltek.com/ma in.html.

VOLARA® foams are commercially sold in Grades A, EO, G, M, TS, AS, RS,and VS. The basic differences among them are indicated by the data ofTable 1 below. Also, the specifications for Grade EO VOLARA® foam aregiven by Table 2 below.

TABLE 1 VOLARA foams Grade Properties A Mid Range; EO Flexibility &softness; G Increased flexibility & softness; M Higher temperatureresistance, and stiffness; TS High strength tape substrate; AS Tough,enhanced vacuum formability; RS High performance pressure formingproperties, high temperature resistance, and stiffness; VS Highperformance pressure forming properties, high temperature resistance,and stiffness.

TABLE 2 Grade EO of VOLARA ® foam Specifications: Closedcell/ethylene-ether foam/Type EO 4 pcf Color: Black or white Density:3.6-4.4 lbs/cubic foot Compression strength 6 psi at 25%; 17 psi at 50%(ASTM D3575): Tensile strength, machine direction 140 psi (ASTM D3575):Tensile strength, cross-machine 99 psi direction (ASTM D3575):Elongation to break, machine 335% direction (ASTM D3575): Elongationcross-machine direction 362% (ASTM D3575): Tear resistance, machine 20lbs./inch direction (ASTM D3575): Tear resistance, cross-machine 17lbs./inch direction (ASTM D3575): Compression set (ASTM D3575): 11% oforiginal thickness Shore hardness (ASTM D2240), 10 A scale: Shorehardness (ASTM D2240), 51 OO scale: Thermal stability, 24 hrs. at 158°F., −1.7% maximal machine direction: Thermal stability, 24 hrs. at 158°F., −1.2% maximal cross-machine direction: Thermal conductivity K factor0.30 BTU/(hr)(ft2)(° F./in) at 70° F.: R Factor − Thickness/ K FactorWater absorption, (ASTM D1667): 0.04 lbs/sq. foot

The base substrate of the manufactured mattress (the planar tier holdingand maintaining the head cavity and the torso recess as discrete spatialdepressions, and forming the substance of the supporting material) ispreferably constructed of VOLARA® foam type 12AW, having a density of 12lbs. per cubic foot. Other alternative closed cell foams that may beused in making the base substrate of the molded mattress are Pelite,Plastizote, T-foam, or other foams having a density of approximately 12lbs per cubic foot.

Equally important, the chosen foam employed as the material for the basesubstrate must be thermoformable. In preferred embodiments of thepre-molded mattress, the maximal girth of the base substrate in themattress is typically about 75 mm in thickness—because the basesubstrate material of the mattress must be sufficiently thick to supportthe infant's head and torso when placed into the molded spatial cavitiesprepared for them. Accordingly, for this purpose, it is also expectedthat the foam used for the base substrate may vary in overall thicknessfrom about 50-100 mm.

V. The Intended Method for Using the Orthotic Device

The prepared pad or mattress comprising the present orthotic device isdesigned for infants ranging in age from birth up to 4 months of age.This time frame is medically considered to be the most critical. It istherefore recommended that the infant be placed in the orthoticdevice—regardless of whether it be in the form of a pad, mattress orpillow—on each occasion that the infant is placed at or lies in a supineposition, or when the infant's occiput could make contact with a flatsurface (e.g., a car seat, stroller, etc.).

The orthotic device is intended for and is expected to be used withinfants below 4 months of age, since such infants usually lacksufficient motor control to roll over or otherwise escape from the pad,mattress or pillow. Infant mobility after about 4 months of age usuallyprecludes successful use of the medical device. If there is significanthead asymmetry or flattening in an infant older than 4 months, a moldinghelmet should be considered.

Specific instructions and advice for the use of the orthotic device ofthe present invention can be provided to parents and child caretakers.Such instructions and advice can be provided in written, audio, or videoform; and will typically include the following:

-   -   How to adjust the bed, pad or mattress article in order to        provide the best possible fit for each infant individually.    -   A listing of specific times (hours per day) considered to be        best and highly recommended for use.    -   Guidelines for when to remove one or more discrete layers of        solid material from each array of layers then disposed within        the head cavity and torso recess.    -   Tools and aids for measuring the infant's head and torso in        order to facilitate the timing of the removal of single layers        of material from the head cavity and torso recess.    -   Instruments with which to measure to the extent of posterior        plagiocephaly initially and by which to determine the degree of        rounding improvement in the head shape of the infant over time.

IV. Clinical Experience and Resulting Empirical Data

To demonstrate the merits and value of the present invention, a seriesof planned experiments and empirical data are presented below. It willbe expressly understood, however, that the experiments described hereinand the results provided below are merely the best evidence of thesubject matter as a whole which is the present invention; and that theempirical data, while limited in content, is only illustrative of thescope of the present invention as envisioned and claimed.

An illustrative recitation and representative example of the presentinvention is the preferred manner and mode for practicing themethodology is also presented below as part of the experimental method.It will be expressly understood, however, that the recited steps andmanipulations presented below are subject to major variances and markedchanges in the procedural details; all of which are deemed to be routineand conventional in this field and may be altered at will to accommodatethe needs or conveniences of the practitioner.

The Clinical Study

The initial prototype of the orthotic device—described as alternativeembodiment 2 previously herein—was used to treat plagiocephalyclinically in infants younger than 4 months of age (at the time ofinitial evaluation). All patients participating in the study wereevaluated and treated in the practice of Dr. Gary F. Rodgers, Divisionof Plastic Surgery, Children's Hospital Boston (Boston, Mass.).

Materials and Methods

Twenty Six (26) patients underwent treatment of plagiocephaly using acustomized and individually fitted head cavity [there was no torsorecess as such in the orthotic device]. Each head cavity was preparedand individually adjusted in spatial volume and size dimensions bylicensed orthotists from the National Orthotic and Prosthetic Company(Boston Brace).

A control group of 23 infants diagnosed with plagiocephaly, prior to thepresent study, were treated and managed only using parental positioningof the infant; and these data were available for use as a comparisonbasis. The gestation age, age at initial examination, and age atfollow-up examination, were all recorded. All patients underwent pre-and post-treatment cephalometric evaluation of the transcranialdifference (a measure of the calvarial obliquity) using head calipers.Statistical analysis of all variables was performed using SAS software.

Empirical Results

The mean transcranial different in the treatment group using the presentorthotic device improved from 11.3 mm to 3.4 mm over an averagetreatment time interval of 70.4 days. In comparison, the meantranscranial difference in the earlier control group showed animprovement from 9.0 mm to 8.0 mm, over a mean treatment time intervalof 61.6 days. The difference was statistically significant (p=0.000).

The variables that were found not to be statistically significantincluded:

-   -   gestation age (39 weeks control group, 38 weeks treatment group;        p=0.052);    -   age at initial evaluation (88 days control group, 98 days        treatment group; p=0.177);    -   initial transcranial differences (9 mm control group, 11.3 mm        treatment group; p=0.057);    -   differences in neck rotation at initial evaluation (38 degrees        control group, 43.7 degrees treatment group; p=0.276);    -   neck rotation at final examination (13.9 degrees control group,        15.4 degrees treatment group; p=0.451);    -   days from initial examination to final examination (61.6 days        control group, 70.4 days treatment group; p=0.69).

Conclusions

The present orthotic device comprising a head cavity which is adjustablein its dimensions and available spatial volume is highly effective inclinically restoring normal head symmetry for infants under 4 months ofage. In comparison, the technique of positioning and re-positioning theinfant as he lies in a supine position was clinically ineffective.

The present invention is not to be limited in form nor restricted inscope except by the claims appended hereto.

1. An orthotic bed comprising: a base substrate having fixed dimensionsand configuration; an anatomically correcting concave head cavity moldedinto said base substrate able to receive and support the occiput of aninfant's head; a plurality of discrete layers of foam material servingas a series of prepared individual layers positioned one over the otheras multiple strata in overlay array series within the molded spatialvolume of said head cavity, said layers being individually removable atwill from the positioned overlay series lying within the spatial volumeof said concave head cavity, and, via their presence within said concavehead cavity, can alter the available spatial volume presented by saidhead cavity for the occiput of an infant's head; and a bridge sectionadjacent to said head cavity serving to support the neck of a infant andto off-load pressure between the infant's occiput and the restingsurface of the head cavity.
 2. The orthotic bed as recited in claim 1wherein said base substrate is comprised of thermoformable material. 3.The orthotic bed as recited in claim 1 wherein said foam is closed cell,ethylene-ether foam.
 4. The orthotic bed as recited in claim 1 whereinsaid base substrate ranges from 50-100 mm in thickness.
 5. The orthoticbed as recited in claim 1 wherein each of said discrete layers of saidhead cavity ranges from 2-6 mm in thickness.
 6. The orthotic bed asrecited in claim 1 wherein the number of said discrete layers of saidhead cavity varies from 3-12 layers.
 7. The orthotic bed as recited inclaim 1 wherein each of said discrete layers of material is labeled forindividual identification and proper positioning in said overlay series.8. The orthotic bed as recited in claim 1 wherein each of said discretelayers of material is colored with a differentiating color.
 9. Anorthotic bed comprising: a base substrate having fixed dimensions andconfiguration; an anatomically correcting concave head cavity moldedinto said base substrate able to receive and support the occiput of aninfant's head; a plurality of discrete layers of foam material servingas a series of prepared individual layers positioned one over the otheras multiple strata in overlay array series within the molded spatialvolume of said concave head cavity, said layers being individuallyremovable at will from the positioned overlay series lying within thespatial volume of said head cavity, and, via their presence within saidconcave head cavity, can alter the available spatial volume presented bysaid head cavity for the occiput of an infant's head; a concave torsorecess molded into said base substrate able to receive and support thetorso of an infant's body; and a plurality of discrete layers of foammaterial serving as a series of prepared individual layers positionedone over the other as multiple strata in overlay array series within themolded depth dimension of said concave torso recess, said layers beingindividually removable at will from the positioned overlay series lyingwithin the molded depth dimension of said concave torso recess, and, viatheir presence within said torso recess, can alter the availabledimensional depth presented by said torso recess for supporting aninfant's torso.
 10. The orthotic bed as recited in claim 9 furthercomprising a bridge section adjacent to said head cavity and torsorecess which serves to support the neck of a infant and to off-loadpressure between the infant's occiput and the resting surface of thehead cavity.
 11. The orthotic bed as recited in claim 9 wherein saidbase substrate is comprised of thermoformable material.
 12. The orthoticbed as recited in claim 9 wherein said foam is closed cell,ethylene-ether foam.
 13. The orthotic bed as recited in claim 9 whereinsaid base substrate ranges from 50-100 mm in thickness.
 14. The orthoticbed as recited in claim 9 wherein each of said discrete layers of saidhead cavity ranges from 2-6 mm in thickness.
 15. The orthotic bed asrecited in claim 9 wherein the number of said discrete layers of saidhead cavity varies from 3-12 layers.
 16. The orthotic bed as recited inclaim 9 wherein each of said discrete layers of said torso recess rangesfrom 2-6 mm in thickness.
 17. The orthotic bed as recited in claim 9wherein the number of said discrete layers of said torso recess variesfrom 3-12 layers.
 18. The orthotic bed as recited in claim 9 whereineach of said discrete layers of material is labeled for individualidentification and proper positioning in said overlay series.
 19. Theorthotic bed as recited in claim 9 wherein each of said discrete layersof material is colored with a differentiating color.